The Biostatistics Core, provides expert management of the design as well as analysis of clinical trials and preclinical research. The two main areas of activity focus on: 91) design monitoring and analysis of clinical trials and (2) data management. The development of an Institutional Clinical Research Database (CRDB) using the ORACLE database system represents an important mechanism to maintain clinical data from various disciplines and research projects. Data audits insure that regular review and quality control of the data. This Core is crucial to the effective management and integration of the large complex data in the Program Project.